Study Evaluated Standardized, Novel, Enriched Biologic for Ocular Graft-vs.-Host Disease
ATLANTA, GA – March 5, 2020 – Cambium Medical Technologies, a clinical stage company developing novel processed platelets for therapeutic applications, today announced receipt of results from a Phase I/II study of its Elate Ocular® topical fibrinogen-depleted human platelet lysate. The biologic was tested among dry eye patients with Ocular Graft-vs-Host Disease (oGvHD). A clinical study report will be submitted to the FDA in early 2Q. Cambium will be presenting and publishing study results in the coming months.
“Our Elate Ocular® biologic significantly exceeded expectations,” said Terry Walts, Cambium’s President and CEO. “These results are especially impressive given the severe nature of oGvHD. The study’s primary objective was safety. Our results suggest our biologic is very well tolerated. The study also assessed efficacy on an exploratory basis. Of note, we exceeded expectations on many efficacy measures, particularly impressive given safety studies are not generally powered to determine efficacy statistical significance,” said Walts.
Cambium believes these results, along with Orphan Drug Designation awarded to the company by the FDA recently, continue to support Elate Ocular’s® potential for dry eye going forward.
Cambium’s current study was a Phase I/II randomized, multicenter, double-masked placebo-controlled parallel trial designed to determine safety and exploratory efficacy in patients with dry eye secondary to oGvHD. The study enrolled a total of 66 patients at nine U.S. eye centers. A placebo and two study drug cohorts were involved.
About Cambium Medical Technologies
Founded in 2013 by four distinguished physician/scientists at Emory University, Atlanta, Georgia (USA)—Cambium is focused on the development of regenerative therapies through novel processed human platelets. Cambium’s Mission: To improve patients’ quality of life—from within. The Company’s first FDA-approved therapy is targeted to be Elate Ocular®, a topical biologic eye drop for dry eye disease (keratoconjunctivis sicca or KCS). Elate Ocular® contains Aurarix®, Cambium’s novel processed enriched platelet-rich-plasma (PRP) lysate. Cambium’s Aurarix® contains over 30 key nutritive/regenerative components documented important to corneal health. The Company believes a complex, multi-component therapeutic like Elate Ocular® may be required to better addressing the complex, multifactorial nature of dry eye. Cambium’s Aurarix® is currently sold worldwide in the stem cell growth supplement market under the names UltraGRO™-Advanced and UltraGRO™ -PURE by Cambium’s strategic partner AventaCell Biomedical Corp., Ltd, a subsidiary of Zheng Yang Biomedical Technology Co., Ltd, Taipei, Taiwan.
For more information about Cambium, contact David Doolittle at email@example.com or go to www.cambiumbio.com. To learn more about AventaCell and their line of UltraGRO™ stem cell growth supplements, contact William D. Milligan at firstname.lastname@example.org or visit www.atcbiomed.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Act”) and are intended to be covered by the safe harbors created thereby. These forward-looking statements include, but are not limited to, statements regarding the expected benefits of the Company’s technologies, investment in product development, possible future financings or other activities and/or statements preceded by, followed by or that include the words “believes,” “could,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “projects,” “seeks,” “potential,” “targets” or similar expressions. Investors are cautioned that all forward-looking statements involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements for any reason. All forward-looking statements speak only as of the date of this press release and the Company undertakes no obligation to update such forward-looking statements.